Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
OBJECTIVES:
Primary
- Determine the complete response and partial response rates in patients with recurrent
or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.
Secondary
- Determine the overall and failure-free survival of patients treated with the
chemotherapy regimen.
- Determine the duration of response (complete or partial) in patients treated with this
regimen.
- Determine the percentage of patients who experience a 50% fall of serum
carcinoembryonic antigen levels with a baseline elevation of > 5 U/mL after receiving
this regimen.
- Evaluate the toxicity associated with the administration of this regimen in these
patients.
OUTLINE: This is a non-randomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV
over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Response Rate as Measured by RECIST Criteria
Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.
4 - 6 months
No
Caio Max S. Rocha Lima, MD
Study Chair
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
EPROST-20030655
NCT00276861
September 2005
May 2008
Name | Location |
---|---|
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |